Advertisement

Experience from a National Quality Assurance System on Radiopharmaceuticals

  • Knud Kristensen

Abstract

Safety, efficacy and uniformity are as important for radiopharmaceuticals as for other drugs. This was recognized in Denmark in the sixties and a national system established during the years 1970–74. Table one gives some statistical information as background information for a description of this national quality assurance system. The development in nuclear medicine in-vivo procedures is given in Figure one.

Keywords

Good Manufacture Practice Nuclear Medicine Department External Contamination Defect Report Hospital Preparation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    K.Kristensen and E.Norbygaard (editors), Safety and efficacy of radiopharmaceuticals,Martinus Nijhoff Publishers Boston (1984).Google Scholar
  2. 2.
    K.Kristensen and E.Norbygaard (editors), Safety and efficacy of radiopharmaceuticals 1987,Martinus Nijhoff Publishers Boston (1987).Google Scholar
  3. 3.
    Good Practice in the Manufacture of Radiopharmaceuticals. A proposal put forward by a group of Pharmacists from the Nordic countries. Arch Pharm Chem 78: 1002–1009 (1971).Google Scholar
  4. 4.
    Draft supplementary guidelines for the manufacture of radiopharmaceuticals April 1990 (EEC 111/3937/89-EN).Google Scholar
  5. 5.
    EFTA,Basic Standards of Good Manufacturing Practice for Pharmaceutical Products,Document PH 3/83(Revised version),EFTA Secretariat,Geneva (1983).Google Scholar
  6. EFTA,Guidelines for the Manufacture of Sterile Products,Annex to the Basic Standards of Good Manufacturing Practice for Pharmaceutical Products (PH 1/72),Document PH 1/81,EFTA Secretariat,Geneva(1981).Google Scholar
  7. 6.
    K.Kristensen,Th.Müller and B.A.Rhodes, Good Radiopharmacy Practice in Quality Control in Nuclear Medicine p.268–275 (editor B A Rhodes)Mosby,St.Louis(1977).Google Scholar
  8. 7.
    K.Kristensen, Preparation and Control of Radiopharmaceuticals in Hospitals, IAEA,Vienna(1979).Google Scholar
  9. 8.
    Radiopharmacy.Preparation and Control of radiopharmaceuticals in hospitals.Nordic guidelines.Nordic Council of Medicines,Uppsala(1989) (ISBN 91–86432–25–7).Google Scholar
  10. 9.
    European Association of Nuclear Medicine (1989) Newsletter 3.Eur J Nucl Med 15:11(1989).Google Scholar

Copyright information

© Springer Science+Business Media New York 1991

Authors and Affiliations

  • Knud Kristensen
    • 1
  1. 1.The Isotope-PharmacyNational Board of HealthCopenhagen (Brønshøj)Denmark

Personalised recommendations